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The effect of squill Oil on the dyspareunia and sexual satisfaction in menopause women

Protocol summary

Study aim
the Effect of Squill Oil on the Dyspareunia and Sexual Satisfaction in Menopause Women
Design
A clinical trial with a control group, with a parallel, blind, randomized clinical trial.Random Type: Simple by using odd and even numbers. Sample size based on estimation with a power of 90% and a 95% confidence coefficient of 26 were calculated for each group, with a probability of 20% of the sample drop, 30 people in each group were considered
Settings and conduct
Qualified samples referring to health canters are randomly divided into two groups. Oils have similar appearance and they are placed into similar boxes by Pharmacist. Only after the end of the study, the name and characteristic of the subject that is written on the box will be revealed. The researcher, supplier, data collector, and data analysis will not be informed of the type of intervention received.
Participants/Inclusion and exclusion criteria
45-65year, complaining of dyspareunia. Exit criteria: Vaginal infection (bacterial vaginosis, trichomonas), any major genital disease (PID, uterine prolapse, cystocele, rectocele), hormone therapy, use of phytoestrogen drugs.
Intervention groups
In the intervention group for 4 weeks, 1 to 3 times a week, and 5 minutes before having sex, 3 cc (equivalent to one teaspoon) should be rubbed gently and roundly on clitoral area and vagina. In the control group, olive oil for 4 weeks, 1 to 3 times a week and 5 minutes before having sex, 3 cc (equivalent to one teaspoon) should be rubbed gently and roundly on clitoral area and vagina.
Main outcome variables
The primary outcome is dyspareunia and the secondary outcome is sexual satisfaction that measured by the relevant questionnaires. Time point: Before intervention, 4 weeks after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170430033718N4
Registration date: 2019-03-17, 1397/12/26
Registration timing: registered_while_recruiting

Last update: 2019-03-17, 1397/12/26
Update count: 0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 795 8503
Email address
karimifr941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of squill Oil on the dyspareunia and sexual satisfaction in menopause women
Public title
The effect of Squill Oil on the dyspareunia and sexual satisfaction in menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Giving a written consent Having literacy Being iranian and living in Mashhad Age 45 t0 65 years Married and having an intact marriage Do not have chronic medical history that affect on sexual function Having sex Pass at least one year from the last menstruation Complaints from the dispareunia (earning at least one rating based on the Marinof scale score)
Exclusion criteria:
Vaginal infection(vaginose bacteriana, tricomonasis) Any major diseases of the genital tract (PID, uterine prolapse, cystocele, rectocele) Hormone therapy or sexual hormones consumption within 8 weeks before the study Smoking and Alcohol Women with uterine bleeding or spotting and the high consumption of other phytoestrogenic drugs (soy, red clover, fenugreek,Vitex agnus) over the past month
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and will be placed inside the envelope. The envelopes will be closed and its contents are not visible from the outside. Then, the purpose of the study is explained to the person who follows the conditions, and the person, if desired, signs the informed consent form and removes an envelope, then opens it and, based on the contents of the envelope, enters into the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The preparation of the envelopes will be done by the person not involved in the collection and analysis of the data. In this way, the participants, prescriber, data collector and data analyzer will not be aware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of MashhadUniversity of Medical Sciences
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
91778774896
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.082

Health conditions studied

1

Description of health condition studied
dyspareunia
ICD-10 code
N94.1
ICD-10 code description
Dyspareunia

Primary outcomes

1

Description
dyspareunia
Timepoint
Before intervention and 4 weeks after the intervention
Method of measurement
Marinof dyspareunia scale

2

Description
sexual satisfaction
Timepoint
Before intervention and 4 weeks after the intervention
Method of measurement
sabbatsberg sexual satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: for 4 weeks, 1 to 3 times a week, and 5 minutes before having sex, 3 cc (equivalent to one teaspoon) should be rubbed gently and roundly on clitoral area and vagina
Category
Treatment - Drugs

2

Description
Control group: olive oil for 4 weeks, 1 to 3 times a week and 5 minutes before having sex, 3 cc (equivalent to one teaspoon) should be rubbed gently and roundly on clitoral area and vagina
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Banafsheh health center
Full name of responsible person
Dr Hashem Alizadeh
Street address
No. 3, Sajedi Ave., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9876540987
Phone
+98 51 3767 3922
Email
farzanekarimi83@gmail.com

2

Recruitment center
Name of recruitment center
Abkou health center
Full name of responsible person
Dr Alizadeh
Street address
Janbaz Ave., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
6758940987
Phone
+98 51 3767 3922
Email
farzanekarimi83@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9876543213
Phone
+98 51 3879 6405
Email
farzanekarimi83@gmail.com
Grant name
Grant code / Reference number
971309
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Farzane Karimi
Position
Masters of Midiwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
91778774896
Phone
+98 936 795 8503
Email
karimifr941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Rahele Babazadeh
Position
Assiatant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
0098
Email
babazader@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Farzane Karimi
Position
masters degree
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9184879418
Phone
+98 936 795 8503
Email
karimifr941@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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